Gelonghui, April 23 | Kangzhe Pharmaceutical (00867.HK) announced that the new drug marketing license application (NDA) for desidustat tablets (former name: dudostat tablets) was accepted by the China National Drug Administration (NMPA) on April 22, 2024. The product is an innovative oral hypoxia-inducible factor-proline hydroxylase inhibitor (HIF-PHI), intended for the treatment of anemia in non-dialyzed adult patients with chronic kidney disease (CKD).
CKD patients gradually lose kidney function and eventually develop kidney failure. Healthy kidneys naturally secrete erythropoietin (EPO), a hormone that boosts red blood cell production. If kidney function is impaired, the level of EPO production decreases or the kidneys do not produce EPO at all, leading to anemia. HIF-PHI promotes erythropoiesis by increasing the production of endogenous erythropoietin, improving iron utilization, and reducing the level of iron modulin.
It is estimated that there are more than 120 million CKD patients in China. Anemia is one of the common complications of CKD. According to a domestic survey, the prevalence of anemia among CKD stage 1 to 5 patients was 22.0%, 37.0%, 45.4%, 85.1%, and 98.2% in that order. However, the treatment compliance rate (hemoglobin (Hb) level reaching the target value (110 to 120 g/L)) was only 8.2% for patients with non-dialysis CKD anemia, and only 35.2% for patients with CKD anemia on hemodialysis, indicating that there is a huge unmet need for treatment.
The product achieved positive results in phase III clinical studies in China. The results of the main study endpoint Hb level (change in hemoglobin mean value relative to baseline in weeks 7-9) showed that the test group was superior to the placebo group. The participants were analyzed using a covariance model. At weeks 7-9, the minimum square mean of Hb and 95% CI in the test group compared to the placebo group and its 95% CI were 16.38 g/L [95% CI: 14.50, 18.26] and -1.13 g/l [95% CI: -3.68, 1.41], and -1.13 g/l [95% CI: -3.68, 1.41], and -1.13 g/l [95% CI: -3.68, 1.41], the difference (test group placebo group) and 95% CIg17.52/ l [95% CI: 14.353, 20.681], 95% CI lower limit is greater than 0.
The product uses oral administration, which is expected to improve patients' compliance with treatment, and is expected to meet unmet treatment needs in the field of CKD anemia (including dialysis and non-dialysis patients). The product has been approved for sale in India.